Tags : 1L

Pfizer’s Vizimpro (Dacomitinib) Receives the US FDA Approval for 1L

Shots: The approval is based on P-III ARCHER 1050 study assessing Vizimpro 45mg vs Gefitinib 250mg in a ratio (1:1) in patients with unresectable, mNSCLC harboring EGFR, exon 19 deletion or exon 21 L858R substitution mutations, with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 mos. disease-free after completion […]Read More

Merck’s (KEYTRUDA in combination with ALIMTA and Pt CT) Receives

Shots: The approval is based on KEYNOTE-189 P-III study, assessing (KEYTRUDA + pemetrexed ALIMTA and Pt CT vs CT alone) administering KEYTRUDA 200 mg, cisplatin/carboplatin, and pemetrexed q3w IV for four cycles followed by KEYTRUDA 200 mg for up to 24 mos and pemetrexed q3w or (PBO + cisplatin/carboplatin and pemetrexed) q3w IV for four […]Read More

Eisai and Merck Annouces the US FDA Approval of Lenvima

Shots: Approval is based on positive results of Ph III REFLECT study showing improved OS, PFS and ORR REFLECT results (Lenvima vs Sorafenib): mOS (13.6 vs 12.3 mos), mPFS (7.3 vs 3.6 mos); ORR (41% vs 12%) with AE ≥20% patients & SAEs ≥2%   Lenvima has been approved in Japan in H1’18 for HCC […]Read More